Ephedrine Sulfate

Product NDC
16714-037
11-digit product format
167140037
Labeler code
16714
Product ID
16714-037_ab525532-8541-49b9-ba78-c39ebdc4c60d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ephedrine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
NorthStar Rx LLC
Application
ANDA212932
Marketing category
ANDA
Marketing start
2020-12-02
Substance
EPHEDRINE SULFATE
Active strength
50 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ephedrine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPHEDRINE SULFATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU6X61U5ZEG
Rxcui1116294

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1bd959e-e326-44fb-b8ca-8c56a84a2a3dProduct name220251211
f1d178e1-1663-4c63-ae37-62a1b322fba4Product name220251106
f606d3ac-dd63-4b29-bea0-db23753b8ddcProduct name120220118
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
30254138-2d98-4aa2-8e07-ae82e8b0a389Product name320171103
fee762de-ffd9-404d-8bc6-8c0c208e758dProduct name120170426
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-037-01Ephedrine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION18
16714-037-10Ephedrine Sulfate10 in 1 CARTONINJECTION108
16714-037-25Ephedrine Sulfate25 in 1 CARTONINJECTION258

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-037-01ML - Milliliter16714-0375eeafb9b-27eb-44c6-a9b2-d18579ee9b5212021-11-09
16714-037-10ML - Milliliter16714-03780d30f89-2063-49fe-963f-05c6f584ae4012021-11-09
16714-037-25ML - Milliliter16714-037aebf152c-e9d1-4720-97ef-65c8dec06ebf12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-037EPHEDRINE SULFATE INJECTION [NORTHSTAR RX LLC]8Current NDC, Legacy NDC, 3 package rows20250130_7b29542f-3a32-4113-bb1c-1fbd280046e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1116294ePHEDrine sulfate 50 MG in 1 ML InjectionPSN7b29542f-3a32-4113-bb1c-1fbd280046e28
11162941 ML ephedrine sulfate 50 MG/ML InjectionSCD7b29542f-3a32-4113-bb1c-1fbd280046e28
1116294ephedrine sulfate 50 MG per 1 ML InjectionSY7b29542f-3a32-4113-bb1c-1fbd280046e28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-037-01167140037011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
16714-037-101671400371010 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-10) / 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) 2020-12-020000-00-00NoNoCurrent
16714-037-251671400372525 VIAL, SINGLE-DOSE in 1 CARTON (16714-037-25) > 1 mL in 1 VIAL, SINGLE-DOSE (16714-037-01) 2020-12-020000-00-00NoNoCurrent